Favourable opinion for reimbursement in the prophylaxis of seasonal influenza in children and adolescents with and without comorbidities from 2 years to less than 18 years of age, in accordance with the current vaccination recommendations (HAS opinion of 12 December 2024).
Clinical Benefit
Substantial
The clinical benefit of FLUENZ (trivalent influenza vaccine (live attenuated, nasal)) is substantial for the prophylaxis of seasonal influenza in children and adolescents from 2 to under 18 years of age, in accordance with the current HAS recommendations (opinion of 12 December 2024).
Clinical Added Value
no clinical added value
Considering:
the evidence of vaccination efficacy (VE) with live attenuated vaccines in lowering the incidence of laboratory-confirmed influenza cases (VE of 78%, CI95% = [59; 89]) and influenza syndromes (VE of 31%, CI95% = [20; 40]) based on the Cochrane review of 2018;
the evidence of superiority of the trivalent live attenuated nasal vaccine compared to the trivalent inactivated vaccine in terms of lowering the incidence of laboratory-confirmed influenza cases: RR of influenza (inactivated versus live attenuated) = 0.52, CI95% = [0.22; 0.82] (meta-analysis by Minozzi et al. 2022);
the lack of evidence of an impact in terms of lowering the incidence of acute otitis media, pneumonia, hospital admissions and mortality and without enough clinical evidence to differentiate between the quadrivalent influenza vaccines available (inactivated vaccines or attenuated live vaccines) based on these clinical outcome measures of interest (Cochrane reviews 2018 and 2017, Minozzi 2022, Stuurman 2021 and Sinnathamby study 2022);
the possible benefit of a trivalent, live attenuated nasal influenza vaccine in terms of the better acceptability of this vaccine among children given that needles are not used, which may have a potential positive impact on vaccination coverage;
the potential risk of vaccine virus transmission, with a peak in the incidence of vaccine virus presence 2 to 3 days after vaccination according to the clinical studies;
the Committee deems that FLUENZ (trivalent influenza vaccine (live attenuated, nasal)) provides no clinical added value (CAV V) compared to the other vaccines recommended in the prophylaxis of seasonal influenza in children and adolescents with and without comorbidities from 2 years to less than 18 years of age, in accordance with the current HAS recommendations (opinion of 12 December 2024).
Listen
